legislation-profile
legislation-profile
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (Text with EEA relevance)
Scope
EU legislation harmonises and simplifies pesticide MRLs, and sets a common EU assessment scheme for all agricultural products for food or animal feed. This regulation applies to products of plant and animal origin or parts thereof covered by Annex I.
Exemptions
It shall not apply to the products covered by Annex I where it may be established evidence that they are intended for (a) the manufacture of products other than food or feed; (b) sowing or planting; or (c) activities authorised by national law for the testing of active substances.
Regulatory activities
Submission of application for MRLs (Art. 6) by industry Evaluation of applications by MS (Art. 8) Submission of evaluated applications to the Commission and the Authority (EFSA) (Art.9) Assessment of the existing MRLs by the Authority (Art. 12)
Relevant product types
Yes, list of commodities (see below section 8)
Reference documents
List of commodities for which MRLs are set Regulation EU 752/2014 - additions and modification of examples of related varieties or other products to which the same MRL applies Regulation EU 212/2013 - additions and modification of examples of related varieties or other products to which the same MRL applies Regulation EU 600/2010 - additions and modification of examples of related varieties or other products to which the same MRL applies Regulation EC 178/2006 - food and feed to which pesticide MRLs apply
Obligations based on CLP hazard class
No specific provisions
Obligations based on properties of concerns
No specific provisions
EU-level occupational exposure limits
No specific provisions
EU-level emission limit values
No provision
Substance-centric data source(s) at the EU level
Industry submission system in place
No
Format for industry submission
No
Owner
DG SANTE; DG ENV EFSA
Update process
Setting MRLs The Commission sets a new MRL and amends or removes an existing one after EFSA's opinion. The Commission adopts Regulations for the purpose.
Amendments
Commission Regulation (EC) No 178/2006 of 1 February 2006 Commission Regulation (EC) No 149/2008 of 29 January 2008 Corrigendum to Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto Commission Regulation (EC) No 260/2008 of 18 March 2008 Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 Commission Regulation (EC) No 839/2008 of 31 July 2008 Corrigendum to Commission Regulation (EC) No 839/2008 of 31 July 2008 amending Regulation (EC) No 396/2005 as regards Annexes II, III and IV on maximum residue levels of pesticides in or on certain products Commission Regulation (EC) No 256/2009 of 23 March 2009 Corrigendum to Commission Regulation (EC) No 256/2009 of 23 March 2009 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for azoxystrobin and fludioxonil in or on certain products Commission Regulation (EC) No 822/2009 of 27 August 2009 Corrigendum to Commission Regulation (EC) No 822/2009 of 27 August 2009 amending Annexes II, III and IV to Regulation (EC) No 396/2005 as regards maximum residue levels for azoxystrobin, atrazine, chlormequat, cyprodinil, dithiocarbamates, fludioxonil, fluroxypyr, indoxacarb, mandipropamid, potassium tri-iodide, spirotetramat, tetraconazole, and thiram in or on certain products Commission Regulation (EC) No 1050/2009 of 28 October 2009 Corrigendum to Commission Regulation (EC) No 1050/2009 of 28 October 2009 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products Commission Regulation (EC) No 1097/2009 of 16 November 2009 Corrigendum to Commission Regulation (EC) No 1097/2009 of 16 November 2009 amending Annex II to Regulation (EC) No 396/2005 as regards maximum residue levels for dimethoate, ethephon, fenamiphos, fenarimol, methamidophos, methomyl, omethoate, oxydemeton-methyl, procymidone, thiodicarb and vinclozolin in or on certain products Commission Regulation (EU) No 304/2010 of 9 April 2010 Commission Regulation (EU) No 459/2010 of 27 May 2010 Commission Regulation (EU) No 600/2010 of 8 July 2010 Commission Regulation (EU) No 750/2010 of 7 July 2010 Commission Regulation (EU) No 765/2010 of 25 August 2010 Commission Regulation (EU) No 893/2010 of 8 October 2010 Commission Regulation (EU) No 310/2011 of 28 March 2011 Commission Regulation (EU) No 460/2011 of 12 May 2011 Commission Regulation (EU) No 508/2011 of 24 May 2011 Commission Regulation (EU) No 520/2011 of 25 May 2011 Commission Regulation (EU) No 524/2011 of 26 May 2011 Corrigendum to Commission Regulation (EU) No 524/2011 of 26 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products Commission Regulation (EU) No 559/2011 of 7 June 2011 Commission Regulation (EU) No 812/2011 of 10 August 2011 Commission Regulation (EU) No 813/2011 of 11 August 2011 Commission Regulation (EU) No 978/2011 of 3 October 2011 Commission Regulation (EU) No 270/2012 of 26 March 2012 Commission Regulation (EU) No 322/2012 of 16 April 2012 Commission Regulation (EU) No 441/2012 of 24 May 2012 Commission Regulation (EU) No 473/2012 of 4 June 2012 Commission Regulation (EU) No 556/2012 of 26 June 2012 Commission Regulation (EU) No 592/2012 of 4 July 2012 Commission Regulation (EU) No 897/2012 of 1 October 2012 Commission Regulation (EU) No 899/2012 of 21 September 2012 Commission Regulation (EU) No 34/2013 of 16 January 2013 Commission Regulation (EU) No 35/2013 of 18 January 2013 Commission Regulation (EU) No 212/2013 of 11 March 2013 Commission Regulation (EU) No 241/2013 of 14 March 2013 Commission Regulation (EU) No 251/2013 of 22 March 2013 Commission Regulation (EU) No 293/2013 of 20 March 2013 Commission Regulation (EU) No 500/2013 of 30 May 2013 Commission Regulation (EU) No 668/2013 of 12 July 2013 Corrigendum to Commission Regulation (EU) No 668/2013 of 12 July 2013 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for 2,4-DB, dimethomorph, indoxacarb, and pyraclostrobin in or on certain products Commission Regulation (EU) No 772/2013 of 8 August 2013 Commission Regulation (EU) No 777/2013 of 12 August 2013 Commission Regulation (EU) No 834/2013 of 30 August 2013 Commission Regulation (EU) No 1004/2013 of 15 October 2013 Commission Regulation (EU) No 1138/2013 of 8 November 2013 Commission Regulation (EU) No 1317/2013 of 16 December 2013 Commission Regulation (EU) No 36/2014 of 16 January 2014 Commission Regulation (EU) No 51/2014 of 20 January 2014 Commission Regulation (EU) No 61/2014 of 24 January 2014 Commission Regulation (EU) No 79/2014 of 29 January 2014 Commission Regulation (EU) No 87/2014 of 31 January 2014 Commission Regulation (EU) No 289/2014 of 21 March 2014 Commission Regulation (EU) No 318/2014 of 27 March 2014 Commission Regulation (EU) No 364/2014 of 4 April 2014 Commission Regulation (EU) No 398/2014 of 22 April 2014 Commission Regulation (EU) No 491/2014 of 5 May 2014 Commission Regulation (EU) No 588/2014 of 2 June 2014 Commission Regulation (EU) No 617/2014 of 3 June 2014 Commission Regulation (EU) No 703/2014 of 19 June 2014 Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 Commission Regulation (EU) No 737/2014 of 24 June 2014 Commission Regulation (EU) No 752/2014 of 24 June 2014 Commission Regulation (EU) No 991/2014 of 19 September 2014 Commission Regulation (EU) No 1096/2014 of 15 October 2014 Commission Regulation (EU) No 1119/2014 of 16 October 2014 Commission Regulation (EU) No 1126/2014 of 17 October 2014 Commission Regulation (EU) No 1127/2014 of 20 October 2014 Commission Regulation (EU) No 1146/2014 of 23 October 2014 Commission Regulation (EU) 2015/165 of 3 February 2015 Commission Regulation (EU) 2015/399 of 25 February 2015 Commission Regulation (EU) 2015/400 of 25 February 2015 Commission Regulation (EU) 2015/401 of 25 February 2015 Commission Regulation (EU) 2015/552 of 7 April 2015 Commission Regulation (EU) 2015/603 of 13 April 2015 Commission Regulation (EU) 2015/845 of 27 May 2015 Corrigendum to Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products Commission Regulation (EU) 2015/846 of 28 May 2015 Commission Regulation (EU) 2015/868 of 26 May 2015 Commission Regulation (EU) 2015/896 of 11 June 2015 Commission Regulation (EU) 2015/1040 of 30 June 2015 Commission Regulation (EU) 2015/1101 of 8 July 2015 Commission Regulation (EU) 2015/1200 of 22 July 2015 Commission Regulation (EU) 2015/1608 of 24 September 2015 Commission Regulation (EU) 2015/1910 of 21 October 2015 Commission Regulation (EU) 2015/2075 of 18 November 2015 Commission Regulation (EU) 2016/1 of 3 December 2015 Commission Regulation (EU) 2016/46 of 18 January 2016 Commission Regulation (EU) 2016/53 of 19 January 2016 Commission Regulation (EU) 2016/60 of 19 January 2016 Commission Regulation (EU) 2016/67 of 19 January 2016 Commission Regulation (EU) 2016/75 of 21 January 2016 Commission Regulation (EU) 2016/71 of 26 January 2016 Corrigendum to Commission Regulation (EU) 2016/71 of 26 January 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 as regards maximum residue levels for 1-methylcyclopropene, flonicamid, flutriafol, indolylacetic acid, indolylbutyric acid, pethoxamid, pirimicarb, prothioconazole and teflubenzuron in or on certain products Commission Regulation (EU) 2016/143 of 18 January 2016 Commission Regulation (EU) 2016/156 of 18 January 2016 Commission Regulation (EU) 2016/439 of 23 March 2016 Commission Regulation (EU) 2016/440 of 23 March 2016 Commission Regulation (EU) 2016/452 of 29 March 2016 Commission Regulation (EU) 2016/486 of 29 March 2016 Commission Regulation (EU) 2016/567 of 6 April 2016 Commission Regulation (EU) 2016/805 of 20 May 2016 Commission Regulation (EU) 2016/1002 of 17 June 2016 Commission Regulation (EU) 2016/1003 of 17 June 2016 Commission Regulation (EU) 2016/1015 of 17 June 2016 Corrigendum to Commission Regulation (EU) 2016/1015 of 17 June 2016 amending Annexes II and III to Regulation (EC) No 396/2005 as regards maximum residue levels for 1 naphthylacetamide, 1-naphthylacetic acid, chloridazon, fluazifop-P, fuberidazole, mepiquat and tralkoxydim in or on certain products Commission Regulation (EU) 2016/1016 of 17 June 2016 Commission Regulation (EU) 2016/1355 of 9 August 2016 Commission Regulation (EU) 2016/1726 of 27 September 2016 Commission Regulation (EU) 2016/1785 of 7 October 2016 Commission Regulation (EU) 2016/1822 of 13 October 2016 Commission Regulation (EU) 2016/1866 of 17 October 2016 Commission Regulation (EU) 2016/1902 of 27 October 2016 Commission Regulation (EU) 2017/170 of 30 January 2017 Commission Regulation (EU) 2017/171 of 30 January 2017 Commission Regulation (EU) 2017/405 of 8 March 2017 Commission Regulation (EU) 2017/623 of 30 March 2017 Commission Regulation (EU) 2017/624 of 30 March 2017 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 Commission Regulation (EU) 2017/626 of 31 March 2017 Commission Regulation (EU) 2017/627 of 3 April 2017 Commission Regulation (EU) 2017/671 of 7 April 2017 Commission Regulation (EU) 2017/693 of 7 April 2017 Corrigendum to Commission Regulation (EU) 2017/693 of 7 April 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 as regards maximum residue levels for bitertanol, chlormequat and tebufenpyrad in or on certain products Commission Regulation (EU) 2017/983 of 9 June 2017 Commission Regulation (EU) 2017/978 of 9 June 2017 Corrigendum to Commission Regulation (EU) 2017/978 of 9 June 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 as regards maximum residue levels for fluopyram; hexachlorocyclohexane (HCH), alpha-isomer; hexachlorocyclohexane (HCH), beta-isomer; hexachlorocyclohexane (HCH), sum of isomers, except the gamma isomer; lindane (hexachlorocyclohexane (HCH), gamma-isomer); nicotine and profenofos in or on certain products Commission Regulation (EU) 2017/1016 of 14 June 2017 Commission Regulation (EU) 2017/1135 of 23 June 2017 Commission Regulation (EU) 2017/1164 of 22 June 2017 Commission Regulation (EU) 2017/1777 of 29 September 2017 Commission Regulation (EU) 2018/70 of 16 January 2018 Commission Regulation (EU) 2018/73 of 16 January 2018 Commission Regulation (EU) 2018/78 of 16 January 2018 Commission Regulation (EU) 2018/62 of 17 January 2018 Commission Regulation (EU) 2018/685 of 3 May 2018 Commission Regulation (EU) 2018/686 of 4 May 2018 Commission Regulation (EU) 2018/687 of 4 May 2018 Commission Regulation (EU) 2018/832 of 5 June 2018 Corrigendum to Commission Regulation (EU) 2018/832 of 5 June 2018 amending Annexes II, III and V to Regulation (EC) No 396/2005 as regards maximum residue levels for cyantraniliprole, cymoxanil, deltamethrin, difenoconazole, fenamidone, flubendiamide, fluopicolide, folpet, fosetyl, mandestrobin, mepiquat, metazachlor, propamocarb, propargite, pyrimethanil, sulfoxaflor and trifloxystrobin in or on certain products Commission Regulation (EU) 2018/960 of 5 July 2018 Commission Regulation (EU) 2018/1049 of 25 July 2018 Commission Regulation (EU) 2018/1514 of 10 October 2018 Commission Regulation (EU) 2018/1515 of 10 October 2018 Commission Regulation (EU) 2018/1516 of 10 October 2018 Commission Regulation (EU) 2019/38 of 10 January 2019 Commission Regulation (EU) 2019/50 of 11 January 2019 Corrigendum to Commission Regulation (EU) 2019/50 of 11 January 2019 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 as regards maximum residue levels for chlorantraniliprole, clomazone, cyclaniliprole, fenazaquin, fenpicoxamid, fluoxastrobin, lambda-cyhalothrin, mepiquat, onion oil, thiacloprid and valifenalate in or on certain products Commission Regulation (EU) 2019/58 of 14 January 2019 Commission Regulation (EU) 2019/88 of 18 January 2019 Commission Regulation (EU) 2019/89 of 18 January 2019 Commission Regulation (EU) 2019/90 of 18 January 2019 Commission Regulation (EU) 2019/91 of 18 January 2019 Commission Regulation (EU) 2019/552 of 4 April 2019 Commission Regulation (EU) 2019/973 of 13 June 2019 Commission Regulation (EU) 2019/977 of 13 June 2019 Commission Regulation (EU) 2019/1015 of 20 June 2019 Commission Regulation (EU) 2019/1176 of 10 July 2019 Commission Regulation (EU) 2019/1559 of 16 September 2019 Commission Regulation (EU) 2019/1561 of 17 September 2019 Commission Regulation (EU) 2019/1582 of 25 September 2019 Commission Regulation (EU) 2019/1791 of 17 October 2019 Commission Regulation (EU) 2019/1792 of 17 October 2019 Commission Regulation (EU) 2020/192 of 12 February 2020 Commission Regulation (EU) 2020/703 of 26 May 2020 Commission Regulation (EU) 2020/749 of 4 June 2020 Commission Regulation (EU) 2020/770 of 8 June 2020 Commission Regulation (EU) 2020/785 of 9 June 2020 Commission Regulation (EU) 2020/856 of 9 June 2020 Commission Regulation (EU) 2020/1085 of 23 July 2020 Corrigendum to Commission Regulation (EU) 2020/1085 of 23 July 2020 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorpyrifos and chlorpyrifos-methyl in or on certain products Commission Regulation (EU) 2020/1565 of 27 October 2020 Commission Regulation (EU) 2020/1566 of 27 October 2020 Commission Regulation (EU) 2020/1633 of 27 October 2020 Commission Regulation (EU) 2021/155 of 9 February 2021 Commission Regulation (EU) 2021/590 of 12 April 2021 Commission Regulation (EU) 2021/616 of 13 April 2021 Commission Regulation (EU) 2021/618 of 15 April 2021 Commission Regulation (EU) 2021/644 of 15 April 2021 Commission Regulation (EU) 2021/663 of 22 April 2021 Commission Regulation (EU) 2021/976 of 4 June 2021 Commission Regulation (EU) 2021/1098 of 2 July 2021 Commission Regulation (EU) 2021/1110 of 6 July 2021 Commission Regulation (EU) 2021/1247 of 29 July 2021 Commission Regulation (EU) 2021/1531 of 17 September 2021 Commission Regulation (EU) 2021/1771 of 7 October 2021 Commission Regulation (EU) 2021/1795 of 11 October 2021 Commission Regulation (EU) 2021/1804 of 12 October 2021 Commission Regulation (EU) 2021/1807 of 13 October 2021 Commission Regulation (EU) 2021/1810 of 14 October 2021 Commission Regulation (EU) 2021/1841 of 20 October 2021 Commission Regulation (EU) 2021/1842 of 20 October 2021 Commission Regulation (EU) 2021/1864 of 22 October 2021 Commission Regulation (EU) 2021/1881 of 26 October 2021 Commission Regulation (EU) 2021/1884 of 27 October 2021 Corrigendum, OJ L 382, 28.10.2021, p. 56 (2021/618) Corrigendum, OJ L 382, 28.10.2021, p. 57 (2021/616) Commission Regulation (EU) 2021/2202 of 9 December 2021 Commission Regulation (EU) 2022/78 of 19 January 2022 Commission Regulation (EU) 2022/85 of 20 January 2022 Commission Regulation (EU) 2022/93 of 20 January 2022 Commission Regulation (EU) 2022/476 of 24 March 2022 Commission Regulation (EU) 2022/566 of 7 April 2022 Commission Regulation (EU) 2022/1264 of 20 July 2022 Commission Regulation (EU) 2022/1290 of 22 July 2022 Commission Regulation (EU) 2022/1321 of 25 July 2022 Commission Regulation (EU) 2022/1324 of 28 July 2022 Commission Regulation (EU) 2022/1343 of 29 July 2022 Commission Regulation (EU) 2022/1346 of 1 August 2022 Commission Regulation (EU) 2022/1363 of 3 August 2022 Commission Regulation (EU) 2022/1406 of 3 August 2022 Commission Regulation (EU) 2022/1435 of 26 August 2022 Commission Regulation (EU) 2023/127 of 18 January 2023 Commission Regulation (EU) 2023/129 of 18 January 2023 Commission Regulation (EU) 2023/163 of 18 January 2023 Corrigendum, OJ L 017, 19.1.2023, p. 99 (2022/1363) Commission Regulation (EU) 2023/163 of 18 January 2023 Commission Regulation (EU) 2023/147 of 20 January 2023 Commission Regulation (EU) 2023/173 of 26 January 2023 Commission Regulation (EU) 2023/198 of 30 January 2023 Commission Regulation (EU) 2023/377 of 15 February 2023 Commission Regulation (EU) 2023/466 of 3 March 2023 Commission Regulation (EU) 2023/679 of 23 March 2023 Commission Regulation (EU) 2023/710 of 30 March 2023 Commission Regulation (EU) 2023/1029 of 25 May 2023 Commission Regulation (EU) 2023/1030 of 25 May 2023 Commission Regulation (EU) 2023/1042 of 26 May 2023 Commission Regulation (EU) 2023/1049 of 30 May 2023 Commission Regulation (EU) 2023/1068 of 1 June 2023 Commission Regulation (EU) 2023/1069 of 1 June 2023 Commission Regulation (EU) 2023/1536 of 25 July 2023 Corrigendum, OJ L 71, 9.3.2023, p. 43 (2023/466) Commission Regulation (EU) 2023/1719 of 8 September 2023 Commission Regulation (EU) 2023/1753 of 11 September 2023 Commission Regulation (EU) 2023/1783 of 15 September 2023 Commission Regulation (EU) 2023/2382 of 29 September 2023 Commission Regulation (EU) 2024/246 of 16 January 2024 Commission Regulation (EU) 2024/331 of 19 January 2024 Commission Regulation (EU) 2024/342 of 22 January 2024 Commission Regulation (EU) 2024/344 of 22 January 2024 Commission Regulation (EU) 2024/347 of 22 January 2024 Commission Regulation (EU) 2024/451 of 5 February 2024 Corrigendum, OL L 90095, 9.02.2024, p. 1 (2024/344) Commission Regulation (EU) 2024/1076 of 15 April 2024 Commission Regulation (EU) 2024/1078 of 15 April 2024
